FDA clears a Perspectum 510(k) for Hepatica, a precision oncology decision support tool for liver cancer.
FDA clears a Passage Bio IND application for PBFT02, an adeno-associated virus-delivery gene therapy that is being studied for treating patients with ...
Public Citizen and other advocacy groups voice strong opposition to the potential nomination of Janet Woodcock as FDA commissioner.
FDA says Meitheal Pharmaceuticals is recalling one lot of cisatracurium besylate injection in which some cartons were mislabeled.
FDA clears an Organicell Regenerative Medicine IND for Zofin and its use in treating patients diagnosed with chronic obstructive pulmonary disease.
Cardiac surgeon Hooman Noorchashm asks FDA, Pfizer, and Moderna to consider recommending that vaccines be delayed for those who are recovering from Co...
FDA says it is resuming prioritized drug inspections by investigator staff in China and India.
FDA accepts for review a Bio-Thera Solutions BLA for BAT1706, a proposed biosimilar to Genentechs Avastin (bevacizumab).